TRIVEX SYSTEM RESECTOR HANDPIECE 7210387

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-08 for TRIVEX SYSTEM RESECTOR HANDPIECE 7210387 manufactured by Lemaitre Vascular, Inc..

Event Text Entries

[139344527] We have received the device for evaluation. The handpiece was returned to us with the drive shaft disassembled from the motor unit. The end bell that secures the seal housing to the core tube was also missing. The pcb wires to the end bell were cut and the drive shaft pin and retainer cup were also missing along with seal housings' internal components and bearings. Based on the condition this device was received, the surgeon would not be able to use this device for the phlebectomy procedure. Based on the limited available information we have at this time, we are reporting this incident as we do not have adequate information about how this device was handled after the event at the user facility. The issue was detected during pre-use check and the device was not used in the patient.
Patient Sequence No: 1, Text Type: N, H10


[139344528] During pre-use check, the blades of the resector did not spin.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1220948-2019-00022
MDR Report Key8405620
Date Received2019-03-08
Date of Report2019-03-08
Date of Event2019-02-09
Date Mfgr Received2019-02-08
Device Manufacturer Date2017-12-29
Date Added to Maude2019-03-08
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. PRAGYA THIKEY
Manufacturer Street63 SECOND AVE
Manufacturer CityBURLINGTON MA 01803
Manufacturer CountryUS
Manufacturer Postal01803
Manufacturer Phone7812212266
Manufacturer G1LEMAITRE VASCULAR, INC.
Manufacturer Street63 SECOND AVE
Manufacturer CityBURLINGTON MA 01803
Manufacturer CountryUS
Manufacturer Postal Code01803
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameTRIVEX SYSTEM RESECTOR HANDPIECE
Generic NameHANDPIECE
Product CodeDWQ
Date Received2019-03-08
Returned To Mfg2019-03-06
Catalog Number7210387
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerLEMAITRE VASCULAR, INC.
Manufacturer Address63 SECOND AVE BURLINGTON MA 02148 US 02148


Patients

Patient NumberTreatmentOutcomeDate
10 2019-03-08

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